505(b)(2): It’s A Different Animal
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Roche faces obstacles in acquiring Genentech
28-Jul-2008 - Roche’s proposed $44bn acquisition of Genentech is facing some opposition with Wall Street saying the offer undervalues the company, disquiet among the biotech’s employees and shareholders suing the Swiss giant....
Globalisation of advanced R&D services 'on the rise'
17-Jul-2008 - Pharmaceutical companies in the developed world have already shifted substantial manufacturing and clinical trial work to emerging economies such as China and India, but a new study suggest they are...
GSK opens pipeline up for comment
07-Jul-2008 - New GlaxoSmithKline chief executive Andrew Witty has said the company will allow regulators and other healthcare officials to have a say on the products it advances through development.
US Senator seeks probe into pharma outsourcing
16-Jun-2008 - A US senator has asked the Food and Drug Administration (FDA) for a probe into outsourcing of production for pharmaceuticals, as well as ways to make drugmakers accountable for products...
Pharma must adapt to emerging markets
19-May-2008 - Pharmaceutical companies are having to radically change their practices when it comes to tackling emerging markets such as China, India, Russia and Brazil, according to IMS.
Japan's contract manufacturing awakening
13-May-2008 - 2005 marked the real beginning of contract manufacturing in Japan, which had been held back by an overly-cautious regulatory environment and significant and unique quality and specification demands in the marketplace.
Maturing biopharma creating CMO opportunities
09-May-2008 - As the biopharmaceutical industry matures, new opportunities are being created for biopharmaceutical contract manufacturers.
Changing times for healthcare logistics
28-Apr-2008 - The healthcare logistics industry is currently experiencing a shift toward globalisation, supply chain simplification and delivery specialisation, says an industry expert.
US still dwarfs the clinical scene, despite offshoring trend
08-Apr-2008 - Despite all the hype over clinical trial offshoring, the US still dwarfs the scene, with emerging countries as yet only a blip on the radar, a unique new study reveals.
Big pharma to persist with external reliance
03-Mar-2008 - Big pharma's thirst for external innovation is set to persist amidst the blockbuster drought.
EC 'unlikely to support ban on primate testing'
13-Feb-2008 - The European Commission is unlikely to support an outright ban on the use of non-human primates in research, but has just published a new document which indicates that significant changes...
Emerging markets 'hot' for VC, says KPMG
04-Feb-2008 - Emerging markets, headed by China and India are tipped to remain hot destinations for venture capital (VC) investments this year, according to a recent survey by KPMG.
UK Government plans will stifle innovation, say biotechs
16-Jan-2008 - New UK Government proposals to scrap Capital Gains Tax (CGT) relief will stifle life science innovation, according to a group of biotech small and medium enterprises (SMEs).
Warding off the generic attack
07-Jan-2008 - A recent report has detailed the challenges facing the pharma industry as the generic flood gates open, with the constant advice to start planning early still apparently not heeded by...
No embryo required: human stem cells from the skin
21-Nov-2007 - A startling breakthrough has allowed scientists to create human stem cells from just reprogrammed skin cells, with no embryo and thus, perhaps no ethical dilemma.
South Africa 'underutilised' for clinical trials
20-Nov-2007 - While India, the Asia-Pacific, Eastern Europe and Latin America are all gaining recognition as potential new hot spots, South Africa remains 'underutilised as a clinical trial destination,' according to a...
FDA failure on foreign inspections frightening
05-Nov-2007 - A US government audit has confirmed the Food and Drug Administration's (FDA's) continual lack of inspection of foreign drug manufacturing plants.
Big pharma lends a helping hand
29-Oct-2007 - Despite often attracting a barrage of negative publicity, particularly in regard to a perception of putting profits before people, big pharma firms are still capable of showing their human side...
Pfizer partners in shock after surprise Exubera exit
22-Oct-2007 - We've all cringed at stories of people dumping their partners via text message but in the world of business, Pfizer seems to have taken things to a new level when...
'We are not anti-Asia' says EU chemicals body
09-Oct-2007 - There have been more calls this month to tighten regulations on pharmaceutical ingredient suppliers in the wake of the recent safety concerns emanating from low-cost regions such as China and...
Pharmaceuticals is top R&D spender
08-Oct-2007 - As an increasingly desperate pharma industry strives to fill drug pipelines, the sector has, for the first time, topped a poll of which industries spend the most on research and...
FDA told its safety monitoring of clinical trials not good enough
02-Oct-2007 - The US Food and Drug Administration (FDA) has been called into question again after the release of a damning report, this time suggesting the agency is inadequate in its safety...
Cheap drugs, no profit, just cures
17-Sep-2007 - A group of leading drug developers have set up an international talent network for a 'global assault' on some of the world's deadliest diseases, such as tuberculosis (TB), malaria and...
UK gets go-ahead for hybrid embryo research
06-Sep-2007 - Eight months after the debate started over whether hybrid embryo research should be allowed in the UK, the Human Fertilisation and Embryology Authority (HFEA) has given researchers the thumbs up...
Chinese scientists given freedom to fail
30-Aug-2007 - As part of a drive towards greater innovation, the Chinese government looks set to introduce new laws giving its domestic scientists freedom to tackle complex scientific problems without fear of...
